Bioavailability of BI 44370 TA Drinking Solution or Tablets With and Without a High Fat Meal in Healthy Male and Female Volunteers

NCT02215746 | Completed Phase 1

• 1 other identifier: 1246.2
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this trial was to evaluate the relative oral bioavailability and pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and tolerability of the substances.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax (maximum concentration of the analyte in plasma)

  up to 24 hours after drug administration

• AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 h after drug administration)

  up to 2 hours after drug administration

• AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

  up to 24 hours after drug administration

• tmax (time from dosing to maximum measured concentration)

  up to 24 hours after drug administration

Secondary Outcomes (13)

• %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

  up to 24 hours after drug administration

• AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 24 hours after drug administration

• AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)

  up to 24 hours after drug administration

• λz (terminal rate constant in plasma)

  up to 24 hours after drug administration

• t1/2 (terminal half-life of the analyte in plasma)

  up to 24 hours after drug administration

Study Arms (6)

Treatment A

EXPERIMENTAL

BI 44370 TA drinking solution 100 mg fasted

Drug: BI 44370 powder for oral solution

Treatment B

EXPERIMENTAL

BI 44370 TA drinking solution 100 mg fed

Drug: BI 44370 powder for oral solution; Other: high fat breakfast

Treatment C

EXPERIMENTAL

BI 44370 TA drinking solution 200 mg fasted

Drug: BI 44370 powder for oral solution

Treatment D

EXPERIMENTAL

BI 44370 TA drinking solution 200 mg fed

Drug: BI 44370 powder for oral solution; Other: high fat breakfast

Treatment E

EXPERIMENTAL

100 mg BI 44370 BS as two tablets 50 mg fasted

Drug: BI 44370 tablet

Treatment F

EXPERIMENTAL

100 mg BI 44370 BS as two tablets 50 mg fed

Drug: BI 44370 tablet; Other: high fat breakfast

Interventions

BI 44370 powder for oral solution DRUG

Treatment A; Treatment B; Treatment C; Treatment D

BI 44370 tablet DRUG

Treatment E; Treatment F

high fat breakfast OTHER

Treatment B; Treatment D; Treatment F

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects according to the following criteria based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
• Age ≥21 and ≤55 years
• BMI ≥18.5 and ≤29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR, and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Solutions

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: January 1, 2008
• Primary Completion: April 1, 2008
• Last Updated: August 13, 2014

Record last verified: 2014-08